Traumatic Brain Injury
Conditions
Keywords
Traumatic Brain Injury (TBI), Paraplegia, Acute
Brief summary
This project will develop a wearable rehabilitation robot suitable for in-bed acute stage rehabilitation. It involves robot-guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-TBI including patients who are paralyzed with no motor output. The early acute TBI rehabilitation device will be evaluated in this clinical trial.
Detailed description
Early after TBI, patients often have significant sensorimotor impairment. There is heightened neural excitability, which may be used to facilitate recovery in the acute phase post stroke. However, there has been a lack of effective and practical protocols and devices for early intensive sensorimotor therapy. The proposed randomized clinical trial using a wearable rehabilitation robot, muscle electromyography (EMG), and/or potentially brain electroencephalogram (EEG) signal seeks to provide early intensive sensorimotor training facilitated by real-time audiovisual and haptic feedback, intelligent stretching and sensory stimulation, active movement training through motivating movement games to promote neuroplasticity and reduce sensorimotor impairments. For acute TBI survivors who cannot generate any motor output yet, EMG or EEG may be used to detect the earliest re-emerging motor control signal and the robot can be used to provide demo and feedback of the intended movement.
Interventions
DEVICEMotor relearning training with wearable ankle robot
Ankle motor control relearning training under real-time feedback
DEVICEPassive stretching with wearable ankle robot
Passive stretching under intelligent robotic control
DEVICEGamed-based active movement training with wearable ankle robot
Active movement training through movement games with robotic assistance
DEVICEPassive movement with limited wearable ankle robot
Passive movement in the joint middle range of motion
DEVICEActive movement training with limited wearable ankle robot
Active movement training without robotic assistance
DEVICEAnkle/Wrist torque and motion measurement with limited wearable ankle/wrist robot
Ankle/Wrist torque and motion measurement with no real-time feedback
Sponsors
University of Maryland, Baltimore
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized clinical trial with the study group and control group
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Acute first time unilateral hemispheric stroke (hemorrhagic or ischemic stroke, 24 hours after admission to 1 month post-stroke at the start of the proposed treatment) * Hemiplegia or hemiparesis * 0≤Manual Muscle Testing (MMT)\<=2 * Age 30-85 * Ankle impairments including stiff calf muscles and/or inadequate dorsiflexion
Exclusion criteria
* Medically not stable * Associated acute medical illness that interferes with ability to training and exercise * No impairment or very mild ankle impairment of ankle * Severe cardiovascular problems that interfere with ability to perform moderate movement exercises * Cognitive impairment or aphasia with inability to follow instructions * Severe pain in legs * Severe ankle contracture greater than 15° plantar flexion (when pushing ankle to dorsiflexion) * Pressure ulcer, recent surgical incision or active skin disease with open wounds present below knee
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Lower Extremity (FMLE) | At the beginning and end of 3-week training, and 1 month after the treatment ends] | The Fugl-Meyer Lower Extremity (FMLE) assessment is a measure of lower extremity (LE) motor and sensory impairments. The FMLE scale ranges from 0 to 34, with higher scores indicating better motor function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Active range of motion (AROM) | At the beginning and end of 3-week training, and 1 month after the treatment ends | AROM will be measured in degrees in the ankle joint while subjects use the muscles to move the ankle. |
| Passive Range of Motion (PROM) | At the beginning and end of 3-week training, and 1 month after the treatment ends | Passive Range of Motion PROM will be measured in degrees in the ankle joint while the robot moves the ankle of the subject strongly. |
| Strength of the ankle flexor-extensor muscle | At the beginning and end of 3-week training, and 1 month after the treatment ends | Strength of the ankle flexor-extensor muscle will be measured in Newtons |
| Modified Ashworth Scale (MAS) | At the beginning and end of 3-week training, and 1 month after the treatment ends | The Modified Ashworth Scale is the most widely used assessment tool to measure resistance to limb movement in a clinic setting. Scores range from 0-4, with 6 choices. 0 (0) - No increase in muscle tone; 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement); 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved; 3 (4) - Considerable increase in muscle tone passive, movement difficult; 4 (5) - Affected part(s) rigid in flexion or extension. |
| Berg Balance Scale | At the beginning and end of 3-week training, and 1 month after the treatment ends | The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. The Berg balance scale ranges from 0 to 56. It is a 14-item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. |
| 10-meter Walk Test | At the beginning and end of 3-week training, and 1 month after the treatment ends | The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance at the beginning and end of 3-week training, and 1 month after the treatment ends. It can be employed to determine functional mobility and gait function. |
Countries
United States
Contacts
CONTACTSoh-Hyun Hur
PRINCIPAL_INVESTIGATORLi-Qun Zhang
University of Maryland
Outcome results
None listed